NCT05383209CompletedPhase 2
Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)
A Phase 2, Multicenter, Prospective, Double-masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Sham for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)
Source: ClinicalTrials.gov · Last updated 15 Aug 2025
Brief summary (registry, in English)
A prospective, randomized, double-masked study that evaluated the ocular efficacy and safety of two doses of the EYP-1901 intravitreal (IVT) insert compared to sham.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 77 (actual)
- First submitted
- 10 May 2022
- Start date
- 28 Sept 2022
- Primary completion date
- 12 Feb 2024
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.
- Diseases
- Diabetic eye disease
- NCT number
- NCT05383209
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 77
- From 28 Sept 2022 to the primary completion date, 12 Feb 2024
- 36 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any evidence or documented history of prior focal or grid laser photocoagulation or any pan-retinal photocoagulation (PRP) in the study eye in the last 12 months.
Other
- Presence of any active Center involved-diabetic macular edema in the study eye as determined by the Investigator on clinical examination, or within the central subfield thickness (CST) of the study eye, with a CST threshold greater than 320 microns.
Who the study is looking for
- Participants must have a hemoglobin A1c \<=12%
- Study eye with moderately severe to severe Non proliferative Diabetic Retinopathy (NPDR) (based on the Diabetic Retinopathy Severity Scale (DRSS) levels 47 or 53)
- Best corrected visual acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of \>=69 letters (approximate Snellen equivalent of 20/40 or better).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.